Date: 2021-08-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1314 of 6 August 2021 concerning the extension of the action taken by the Italian Ministry of Health permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 5822) (Only the Italian text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
This Commission Implementing Decision EU 2021/1314 authorises the extension of the action taken by the Italian Ministry of Health regarding the biocidal product Biobor JF. This extension permits the product's availability and use for antimicrobial treatment of aircraft fuel tanks by professional users until 1 November 2022, with retroactive effect from 1 May 2021. The decision addresses concerns about air transport safety due to microbiological contamination.
**Key Points / Main Content:**
* **Extension of Action:**
* The Italian Ministry of Health is permitted to extend the availability and use of Biobor JF.
* The extension applies to the antimicrobial treatment of aircraft fuel tanks and systems.
* The product is to be used by professional users only.
* The extension is valid until 1 November 2022.
* **Justification for Extension:**
* The extension addresses concerns about air transport safety due to microbiological contamination of aircraft fuel systems.
* The COVID-19 pandemic and flight restrictions led to aircraft immobility, exacerbating microbiological contamination.
* Alternative products, such as Kathon FP 1.5, have been withdrawn due to engine anomalies.
* There are currently no identified alternatives for treating the microbiological contamination of aircraft fuel tanks and fuel systems.
* The manufacturer of Biobor JF is pursuing regular authorisation, with an application expected in mid-2022.
* **Active Substances:**
* Biobor JF contains 2,2'-methyltrimethylenedioxybis(4-methyl-1,3,2-dioxaborinane) (CAS number 26651-36) and 2,2'-oxybis(4,4,6-trimethyl-1,3,2-dioxaborinane) (CAS number 14697-50-8).
* These substances are active substances for product-type 6 biocidal products (preservatives for products during storage).
* The substances are not currently part of the work programme for systematic examination of existing active substances.
* **Decision Details:**
* The decision has retroactive effect, applying from 1 May 2021.
* The decision is addressed to the Italian Ministry of Health.
**Impact Analysis:**
**Italian Ministry of Health:**
* *Impact:* Granted permission to extend the availability and use of Biobor JF until 1 November 2022, and is responsible for overseeing its use.
* *Action Required:* Implement the extension of the permission for Biobor JF.
**Professional Users of Biobor JF:**
* *Impact:* Can continue to access and use Biobor JF for antimicrobial treatment of aircraft fuel tanks until 1 November 2022.
* *Action Required:* Continue to use Biobor JF in accordance with existing regulations and guidelines.
**Air Transport Industry (Airlines, Aircraft Maintenance):**
* *Impact:* Ensured availability of a necessary product to control microbiological contamination in aircraft fuel systems, contributing to air transport safety.
* *Action Required:* Continue to follow best practices for fuel tank maintenance and treatment using Biobor JF.
**European Commission:**
* *Impact:* Oversees the implementation of Regulation EU No 528/2012 and addresses requests for extensions of actions related to biocidal products.
* *Action Required:* Monitor the situation and the progress of the Biobor JF manufacturer towards regular authorisation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's budget.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Italian Ministry of Health: The national health ministry of Italy, responsible for public health and healthcare.
Biobor JF: A biocidal product used for the antimicrobial treatment of aircraft fuel tanks and fuel systems.
COVID-19: A global pandemic caused by the SARS-CoV-2 virus, leading to flight restrictions and aircraft immobility.
Commission Delegated Regulation EU No 1062/2014: A regulation concerning the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation EU No 528/2012.
Brussels: The de facto capital city of the European Union, where the Commission Implementing Decision was adopted.
10.8.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 287/9
COMMISSION IMPLEMENTING DECISION (EU) 2021/1314
of 6 August 2021
concerning the extension of the action taken by the Italian Ministry of Health permitting the making
available on the market and use of the biocidal product Biobor JF in accordance with Article 55(1) of
Regulation (EU) No 528/2012 of the European Parliament and of the Council
(notified under document C(2021) 5822)
(Only the Italian text is authentic)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 55(1), third subparagraph,
thereof,
Whereas:
(1) On 12 October 2020 the Italian Ministry of Health (‘the competent authority’) adopted a decision to permit, in
accordance with Article 55(1), first subparagraph, of Regulation (EU) No 528/2012, the making available on the
market for, and use by, professional users of the biocidal product Biobor JF for the antimicrobial treatment of
aircraft fuel tanks and fuel systems until 30 April 2021 (‘the action’). The competent authority informed the
Commission and the competent authorities of the other Member States of its action and the justification for it, in
accordance with Article 55(1), second subparagraph, of that Regulation.
(2) According to the information provided by the competent authority, the action was necessary in order to protect
public health, as the microbiological contamination of aircraft fuel tanks and fuel systems can lead to malfunctions
of the aircraft engine and endanger its airworthiness, thus putting at risk the safety of passengers and crew. The
COVID-19 pandemic and the ensuing flight restrictions led to numerous aircraft being temporarily parked. The
immobility of aircraft is an aggravating factor of microbiological contamination.
(3) Biobor JF contains 2,2'-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) (CAS number 2665-13-6)
and 2,2'-oxybis (4,4,6-trimethyl-1,3,2-dioxaborinane) (CAS number 14697-50-8), active substances for use in
biocidal products of product-type 6 as preservatives for products during storage as defined in Annex V to
Regulation (EU) No 528/2012. As those active substances are not listed in Annex II to Commission Delegated
Regulation (EU) No 1062/2014(2), they are not included in the work programme for the systematic examination of
all existing active substances contained in biocidal products, referred to in Regulation (EU) No 528/2012. Article 89
of that Regulation therefore does not apply to them and they have to be assessed and approved before biocidal
products containing them can be authorised also at national level.
(4) On 26 March 2021, the Commission received a reasoned request from the competent authority to allow the
extension of the action in accordance with the Article 55(1), third subparagraph, of Regulation (EU) No 528/2012.
The reasoned request was made on the basis of concerns that air transport safety might continue to be endangered
by microbiological contamination of aircraft fuel tanks and fuel systems after 30 April 2021 and the claim that
Biobor JF is essential in order to control such microbiological contamination.
(5) According to the information provided by the competent authority, the only alternative biocidal product
recommended by aircraft and engine manufacturers for the treatment of microbiological contamination (Kathon™
FP 1.5) was withdrawn from the market in March 2020 due to severe engine behaviour anomalies noticed after the
treatment with that product.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of
all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament
and of the Council (OJ L 294 10.10.2014, p. 1).L 287/10 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 10.8.2021
(6) As indicated by the competent authority, there are no alternatives for the treatment of microbiological
contamination of aircraft fuel tanks and fuel systems.
(7) According to the information available to the Commission, the manufacturer of Biobor JF has taken steps towards
the regular authorisation of the product and an application for approval of the active substances it contains is
expected to be submitted in mid-2022. The approval of the active substances and subsequent authorisation of the
biocidal product would constitute a permanent solution for the future, but a significant amount of time would be
needed for the completion of those procedures.
(8) The lack of control of microbiological contamination of aircraft fuel tanks and fuel systems might endanger the air
transport safety and that danger cannot be adequately contained by using another biocidal product or by other
means. It is therefore appropriate to allow the competent authority to extend the action.
(9) Considering that the action expired on 30 April 2021, this Decision should have retroactive effect.
(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The Italian Ministry of Health may extend the action to permit the making available on the market for, and use by,
professional users of the biocidal product Biobor JF for the antimicrobial treatment of aircraft fuel tanks and fuel systems
until 1 November 2022.
Article 2
This Decision is addressed to the Italian Ministry of Health.
It shall apply from 1 May 2021.
Done at Brussels, 6 August 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission